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Combination Immunotherapy in Colorectal Cancer

Study acronym: NEST-1
StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 4 more changesShow less
    • Study completion date changed from estimate of Jul 2026 to Nov 14, 2024
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised at 3 of 3 sites
  2. Results first posted: May 22, 2026
    • Secondary endpoints: details revised at 2 of 2 entries
    v11
  3. Trial status: Suspended to Active, Not Recruitingv10 Show 5 more changesShow less
    • Enrollment target: estimated 36 to confirmed 26
    • Primary completion date changed from estimate of Nov 2025 to Nov 14, 2024
    • Study completion date: Jun 2026 to Jul 2026
    • Secondary endpoints: 1 to 2
    • Primary endpoints revised (4)
  4. Trial status: Recruiting to Suspended Sponsor's reason: Study is temporarily paused to review safety data.
    • Primary completion date: May 2025 to Nov 2025
    • Study completion date: Dec 2025 to Jun 2026
    • Site details revised at 3 of 3 sites
    v9
  5. Site contacts updated at 1 of 3 sitesv8
Show 6 earlier versionsHide 6 earlier versions
  1. Eligibility criteria expanded, about 44 wordsv7
  2. Trial status: Active, Not Recruiting to Recruitingv6 Show 9 more changesShow less
    • Enrollment target: 12 to 36
    • Primary completion date: May 2024 to May 2025
    • Primary endpoints revised (4)
    • Study sites: 1 to 3
    • Study completion date: Dec 2024 to Dec 2025
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoint revised
    • Study description shortened, about 24 words
    • Study arms: 1 to 3
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  4. Start date changed from estimate of Mar 2023 to Mar 17, 2023v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  6. Start date: Dec 2022 to Mar 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a pilot study to see whether a combination of two investigational drugs that target the immune system can be given to people with colorectal cancer before surgically removing the tumor. This study is also being done to see what side effects this combination of drugs has and what effect they have on colorectal cancer. The two monoclonal antibodies are balstilimab, a programmed cell death protein 1 (PD-1) inhibitor, and botensilimab, a cytotoxic T lymphocyte-associated protein 4 (CTLA-4) inhibitor. This study has 3 cohorts. Participants in Cohort A will receive a total of 2 doses of balstilimab and a single dose of botensilimab, both given intravenously (IV), before surgery. Participants in Cohort B and C will receive a total of 4 doses of balstilimab and a single dose of botensilimab, both given intravenously (IV), before surgery. Participants in Cohort C must have dMMR/MSI-High colorectal cancer.
Trial Details
NCT Number NCT05571293
Lead Sponsor Weill Medical College of Cornell University
Collaborators: Agenus Inc.
Conditions
(from sponsor)		 Colorectal Neoplasms
Related terms Colorectal Neoplasms, Diabetes Mellitus, Insulin-Dependent, 12
Enrollment 26 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov